Tevogen Bio Reports Its Investigational SARS-CoV-2 Specific T Cell Therapy, TVGN-489, Retains Activity Against the Dominant JN.1 Variant

WARREN, N.J.–(BUSINESS WIRE)–Tevogen Bio Holdings (‘Tevogen Bio’) (Nasdaq: TVGN), today announced TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for treatment of COVID-19 in high-risk patients and Long COVID, retains activity against the currently dominant and highly mutated JN.1 strain based on a review of this variant’s protein sequences.

TVGN 489 contains Cytotoxic T lymphocytes that recognize multiple SARS-CoV-2 proteins, or peptides. TVGN 489’s peptide targets have been preserved in all previously studied COVID strains. Continuing surveillance by Tevogen Bio of SARS-CoV-2 variants, including the currently dominant JN.1 strain and newer JN.1 strains, show that 96% of these CTLs remain active against the current circulating variants.

In January of 2023, Tevogen reported positive phase I study results in which high-risk patients with the delta, omicron 1, and omicron 2 variants of COVID-19 received TVGN 489, manufactured for the trial in May of 2021. In addition to no dose-limiting toxicities or significant treatment-related adverse events being observed in the treatment arm, all patients regardless of variant experienced prompt clinical improvement and a reduced amount of virus in their nasal swabs (>99 to 100% in all patients) within 14 days. “These findings will be further assessed in planned later-stage trials and TVGN 489 will continue to be monitored for target preservation in emerging SARS-CoV-2 variants,” said Dr Dolores Grosso, DNP, Tevogen’s Global Clinical Development Lead.

“We remain committed to developing therapeutic solutions for patients who are highly vulnerable to developing poor outcomes when infected with SARS-CoV-2,” said Tevogen CEO Dr. Ryan Saadi. “I am also highly optimistic about the potential of TVGN 489 to bring much needed relief to millions of Long Covid patients,” he added.

TVGN 489 is manufactured using the ExacTcell platform in which numerous peptides from across a viral genome are selected as targets for the CTLs, mitigating reductions in cytotoxicity from the loss of one target from mutation. In the case of SARS-CoV-2, the entire COVID-19 genome as opposed to just the Spike protein is targeted. The preservation of T-cell targets across nearly five years of viral evolution avoids the need to make frequent changes to the formulation of TVGN 489 and stands in contrast to the loss of monoclonal antibody targets, which has happened far more rapidly in a number of cases.

About Tevogen Bio

Tevogen Bio is a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified precision T cell therapies for the treatment of infectious diseases, cancers, and neurological disorders, aiming to address the significant unmet needs of large patient populations. Tevogen Leadership believes that sustainability and commercial success in the current era of healthcare rely on ensuring patient accessibility through advanced science and innovative business models. Tevogen has reported positive safety data from its proof-of-concept clinical trial, and its key intellectual property assets are wholly owned by the company, not subject to any third-party licensing agreements. These assets include three granted patents and twelve pending patents, two of which are related to artificial intelligence.

Tevogen Bio is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and global product launch experience. Tevogen Bio’s leadership believes that accessible personalized therapeutics are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation.

Forward Looking Statements

This press release contains certain forward-looking statements relating to the Tevogen Bio and its business, including without limitation statements regarding the product candidates, products, markets, and expected future performance and market opportunities of Tevogen Bio, Tevogen Bio’s clinical trial plans, and future target preservation for TVGN 489. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to known and unknown risks and uncertainties that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. Forward-looking statements can sometimes be identified by words such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” and “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which Tevogen Bio expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between Tevogen Bio’s expectations and actual results, including, among others: changes in the markets in which Tevogen Bio competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen Bio may not be able to execute its growth strategies; Tevogen Bio’s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review and approval and commercial development, including the risks that changes to TVGN 489’s target peptides may require additional regulatory approvals and that there is no guarantee Tevogen Bio will receive such approvals; risks associated with intellectual property protection; and other risks related to matters that could affect Tevogen Bio’s future financial results, including the commercial potential, sales, and pricing of Tevogen Bio’s products. Except as required by law, Tevogen Bio undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.

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